- Merck & Co. (Rahway, NJ)
- … policies that support work that is executed in Global Regulatory Affairs and Clinical Safety .Ensure organizational compliance with global regulations ... & Development. This collaboration is essential in developing and executing strategies that support the ongoing business needs of Global Regulatory Affairs and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of SOPs, Work Instructions (WIs) and training materials required to support regulatory labeling-related activities. Updates internal processes to ensure ... FDA databases. This individual acts as the Subject Mater Expert (SME) for electronic reports that are FDA compliant...TVT, ALiCE, novoGlow, etc.). This includes contributing to new regulatory processes and providing training support as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... deviation requests for Daiichi Sankyo and partner companies, if applicable.Ensure Compliance with Labeling Regulations and Guidances: Demonstrate expert … more
- Merck & Co. (Durham, NC)
- …phases of new equipment Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author ... Job Description Job Description: Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety...and international PV regulations. Act as a subject matter expert in regulatory intel for PV and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... deviation requests for Daiichi Sankyo and partner companies, if applicable.Ensure Compliance with Labeling Regulations and Guidances: Demonstrate expert … more
- Merck & Co. (Rockville, MD)
- Job DescriptionThe Science and Regulatory Policy (SRP) team advocates for policy priorities that support the pipeline and portfolio for our Research & ... Development Division and our company's business goals, developing wider support for our causes and maintaining a strong reputation as a science-led biopharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …clean utilities validation activities during project life cycle.You will lead or support overall compliance requirements for the Utilities areas, including SOPs, ... as needed. This role is the site Subject Matter Expert (SME) for site GMP Clean Utilities infrastructure and...ensuring that utilities equipment is maintained to meet GMP requirements. Support utilities areas in Regulatory / FDA… more
- Merck & Co. (North Wales, PA)
- …Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public ... point of contact for our Research & Development Division Serve as an expert on informed consent policy and lead assessment/implementation of policy changes while… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of the pharmaceutical industry including marketing, medical, access, public affairs, compliance , legal and regulatory as well as the healthcare ... and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch Office,… more
- Merck & Co. (Rahway, NJ)
- …pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. - Specifically, The Executive Clinical Director ... plan and Investigational New Drug applications. Providing clinical development support of business development assessments of external opportunities to grow… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to… more
- Merck & Co. (North Wales, PA)
- …provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. - - Under the general scientific and administrative… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA). Support coordination of data collection and trend ... analysis as requested by QA and Regulatory Affairs including the annual report and continued process verification (CPV)Recognize and act on potential compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Portfolio Strategy, Commercial Excellence, Regulatory Affairs, and other relevant NNI departments to ensure alignment of ... to maximize customer centricity across the Rare Bleeding TA Commercialization Strategy Support development of the therapy area/brand value story and positioning to… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... marketed Oncology drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug… more
- Merck & Co. (Rahway, NJ)
- …of Global Clinical DevelopmentMay serve as a senior therapeutic area content expert within the company, providing input into research and business development ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and ... communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making… more
- Aequor (Chattanooga, TN)
- …, and Food and Drug Administration (FDA) regulatory standards. Maintain compliance with all state and federal regulations. Support reduction in environmental ... responsible for providing project management, design engineering, and ad-hoc technical support of packaging and processing operations. They are responsible for all… more
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